Delivering the Goods: Harmonizing Regulated and Agile Practices

Agile testing is hard. Testers contend with terse requirements, minimal process, little documentation, continually evolving business, technical and organizational factors. Auditors demand proof of compliance. Some teams have trouble conforming to regulations while preserving agile practises. Griffin Jones, a tenured regulated software testing consultant, says “not only can agile practices blend with regulatory compliance - they can be harmonized with them leading to high quality and more agility.” Griffin feels that regulators are project stakeholders, who join the product owner in defining value. Griffin shares examples, methods and techniques of implementing regulatory compliant testing as a graceful part of an agile workflow. Learn the five-part harmony binding regulated and agile practices. (1) Establish Specific Goals, (2) Define Deliberate Development, (3) Implement Risk Mitigation, (4) Generate Evidence and (5) Close Gaps. The process is tweaked each retrospective. Auditors assess the completeness, compliance and value of each product increment. Delegates learn how to implement agile regulatory compliance testing, they take away several examples from case studies which may be adapted to their own projects.

Griffin Jones is an Agile consultant and coach, specializing in applying human-centered systems thinking to regulated industries. He has a technical background of over twenty-five years of testing as an individual contributor, Manager, Director, and Consultant - for medical device and pharmaceutical companies, clinical research organizations, banks, and insurance companies. Griffin has been responsible for all matters relating to the establishment and maintenance of a Quality Systems, the execution of verification and validation (testing), and the presentation and representation of results to internal and external regulatory auditors. He is currently a host of the Workshop on Regulated Software Testing (WREST). Reach Griffin at [email protected].